Dried influenza vaccine preparation and method of producing the same

a technology of influenza vaccine and preparation method, which is applied in the field of dried preparation, can solve the problems of economic loss, affecting society, and difficult to distribute preparation, and achieve the effects of stable supply, stable maintenance, and easy distribution and storag

a technology of influenza vaccine and preparation method, which is applied in the field of dried preparation, can solve the problems of economic loss, affecting society, and difficult to distribute preparation, and achieve the effects of stable supply, stable maintenance, and easy distribution and storag

US20160206728A1Inactive Publication Date: 2016-07-21NITTO DENKO CORP
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Examples

Experimental program
Comparison scheme
Effect test

example 1

MEASUREMENT EXAMPLE 1

Measurement of the Activity of the Influenza HA Vaccine

(1) Preparation of a Chicken Erythrocyte Suspension (1 vol %)

[0051]Preserved chicken blood (produced by Nippon Biotest Laboratories Inc.) was placed in a centrifuge tube and centrifuged at 900 G for five minutes. Subsequently, the supernatant and the leukocyte layer were removed. Next, PBS for dilution (a phosphate-buffered sodium chloride solution (pH 7.2)) having the composition described below was added to the erythrocytes in the centrifuge tube, followed by stirring. Then, centrifugation was performed to remove the supernatant. This operation was repeated three times. The erythrocytes in the centrifuge tube were separated out and mixed into a vessel containing a dilute solution. Thereby, a chicken erythrocytes suspension (1 vol %) was prepared.

PBS for Dilution

[0052]Sodium chloride (produced by Wako Pure Chemical Industries, Ltd.) 8.5 g

Disodium hydrogen phosphate 12-hydrate (produced by Wako Pure Chemical...

examples 2 to 17

Lyophilized Influenza HA Vaccine Preparation

[0056]A lyophilized influenza HA vaccine preparation was obtained in the same manner as in Example 1 except that the type or amount of disaccharide or the amount of liquid before lyophilization was changed as shown in Table 2.

examples 18 to 21

Lyophilized Influenza HA Vaccine Preparation

[0059]A lyophilized influenza HA vaccine preparation was obtained in the same manner as in Example 1 except that the amount of the influenza HA antigen was changed as shown in Table 5.

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Abstract

The present invention provides a dried influenza vaccine preparation in which the activity of an influenza vaccine antigen can be stably maintained even when stored without strictly maintaining a low temperature, and which can be stably supplied. The present invention also provides a method of producing the dried influenza vaccine preparation. The present invention provides a dried influenza vaccine preparation containing an influenza vaccine antigen and a disaccharide, wherein the disaccharide is at least one selected from the group consisting of sucrose, maltose, palatinose, melibiose, isomalt, cellobiose, allolactose, isomaltose, sophorose, lactobionic acid, laminaribiose, xylobiose, turanose, gentiobiose, rutinose, kojibiose, nigerose, robinose, neohesperidose, sucralose, and maltitol.

Description

TECHNICAL FIELD[0001]The present invention relates to a dried preparation containing an influenza vaccine antigen. More specifically, the present invention relates to a dried influenza vaccine preparation in which the activity of an influenza vaccine antigen can be stably maintained even when stored without: strictly maintaining a low temperature, and which can be stably supplied. The present invention also relates to a method of producing the dried influenza vaccine preparation.BACKGROUND ART[0002]Influenza is a type of acute infection caused by an influenza virus. The incubation period from infection with the influenza virus to onset of influenza is usually one to two days. The onset is accompanied by the following symptoms, for example: a fever of 38 degrees or higher, systemic symptoms (such as general malaise, headache, joint pain, and muscle pain) , sore throat, cough, and nasal discharge. In general, recovery takes one week or less. Influenza may lead to complications such as...

Claims

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Application Information

Patent Timeline
21 Jul 2016
Publication
US20160206728A1
IPC
A61K39/145; C12N7/00
CPC
A61K39/145; C12N7/00; A61K2039/525; C12N2760/16034; A61K2039/55511; A61K47/26; A61K9/19; A61K39/12
Inventors
KIYOTOH, EIJI; HORI, MITSUHIKO